[Code of Federal Regulations]

[Title 34, Volume 1]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 34CFR97.118]



[Page 309]

 

                           TITLE 34--EDUCATION

 

PART 97_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Subpart A_Federal Policy for the Protection of Human Subjects (Basic ED 

            Policy for Protection of Human Research Subjects)

 

Sec.  97.118  Applications and proposals lacking definite plans for 

involvement of human subjects.



    Certain types of applications for grants, cooperative agreements, or 

contracts are submitted to departments or agencies with the knowledge 

that subjects may be involved within the period of support, but definite 

plans would not normally be set forth in the application or proposal. 

These include activities such as institutional type grants when 

selection of specific projects is the institution's responsibility; 

research training grants in which the activities involving subjects 

remain to be selected; and projects in which human subject's involvement 

will depend upon completion of instruments, prior animal studies, or 

purification of compounds. These applications need not be reviewed by an 

IRB before an award may be made. However, except for research exempted 

or waived under Sec.  97.101 (b) or (i), no human subjects may be 

involved in any project supported by these awards until the project has 

been reviewed and approved by the IRB, as provided in this policy, and 

certification submitted, by the institution, to the department or 

agency.



(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-

1(b))



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